eMDR System Enhancements
This page lists enhancements to CDRH's Electronic Medical Device Reporting (eMDR) system. The FDA eSubmitter client is updated concurrently with the eMDR system, but industry with system-to-system, or AS2, accounts with the FDA Electronic Submissions Gateway (ESG), should use the information on this page to plan system updates to align with these eMDR system enhancements as soon as possible.
The FDA recognizes the importance of providing early notice and predictability about potential eMDR system changes, especially for manufacturers submitting HL7 ICSR XML reports using AS2. Therefore, the FDA is implementing enhancements to the eMDR System on a regular schedule.
Through this schedule, the FDA expects to take the next steps for every cycle of new enhancements:
- Announce upcoming enhancements in June,
- Release the Implementation Package in August,
- Deploy enhancements to pre-production (ESG Test) soon after the package is released, and
- Deploy high-impact enhancements to production 7 months after the Implementation Package is released, typically in March of the following year.
While the FDA expects to follow this schedule for future enhancements, it is possible that emergency fixes may need to be implemented outside the schedule. Additionally, if major system changes are necessary in the future, additional time will be provided between release of the implementation package and production deployment.
We will provide regular communications on this page at each point in the process. This information will also be emailed to the CDRH Industry's email list.
Please contact the eMDR helpdesk at eMDR@fda.hhs.gov for any questions or concerns about specifications and enhancements. Industry with AS2 accounts may use eMDR Test (through ESG Test) for testing system updates at any time.
Upcoming 2023 Enhancements to eMDR
While some changes will be deployed in January 2024, AS2 submitters have until June 1, 2024 to implement these changes.
| Change | Comments | Schedule |
|---|---|---|
| Remove Form Code field | This field is no longer necessary since the Exemption Number field was added. |
December 1, 2023: Test deployment to eMDR. January 2024: Production deployment to eMDR and eSubmitter. |
| No longer accept reports with multiple G4 PMA, 510(k), or device BLA numbers | eMDR currently accepts MDRs with multiple premarket approval/clearance numbers, but only processes the first one provided in the XML. Once this update takes place, submitters who send an MDR with more than one premarket approval number or a number longer than the maximum length for this field will receive an Ack3 rejection message. |
December 1, 2023: Test deployment to eMDR. June 1, 2024: Production deployment to eMDR. |
| Update electronic form labels to Form FDA 3500A (11/22) |
Various labels in eSubmitter, eMDR, and the implementation package will be updated to match the current Form FDA 3500A (11/22). The FDA intends for this change to not require any action by AS2 submitters, but there will be impacts, such as changes to the field numbers in the Ack3 messages. |
December 1, 2023: Test deployment to eMDR. January 2024: Production deployment to eMDR and eSubmitter. |
| Add A3b Patient Gender field | This new field on the Form FDA 3500A (11/22) PDF will be added to eMDR and eSubmitter. The previous A3 Patient Gender field will be mapped to A3a Patient Sex, and a new field will be created for Patient Gender information. |
December 1, 2023: Test deployment to eMDR. January 2024: eSubmitter users can begin using this field. AS2 users to implement this field by June 1, 2024. |
| Add D4 Additional Unique Device Identification (UDI) field | This field was expanded from a single value to multiple values on the Form FDA 3500A (11/22) PDF. The current D4 UDI field will remain on the electronic form and be relabeled to "Primary UDI Number". A new multi-value field will be added to eMDR and eSubmitter to allow submitters to include UDIs other than the primary UDI, which will be helpful for summary reporting. |
December 1, 2023: Test deployment to eMDR. January 2024: eSubmitter users can begin using this field. AS2 users to implement this field by June 1, 2024. |
| Add Organization Name field under F3 contact information | This will allow the importer or user facility company name to be included in each MDR. |
December 1, 2023: Test deployment to eMDR. January 2024: eSubmitter users can begin using this field. AS2 users to implement this field by June 1, 2024. |
| Increase H9 FDA Action Code length to 50 characters | The length of this field is being increased to be consistent with Form FDA 3500A (11/22). |
December 1, 2023: Test deployment to eMDR. January 2024: Production deployment to eMDR and eSubmitter. |
| Add H10 Related Report Numbers field | This new field on the Form FDA 3500A (11/22) will be added to eMDR and eSubmitter. This field will allow submitters to identify one or more other MDRs concerning the same event, such as user facility or voluntary MDRs that reference the same event as a manufacturer MDR. |
December 1, 2023: Test deployment to eMDR. January 2024: eSubmitter users can begin using this field. AS2 users to implement this field by June 1, 2024. |
| Accept manufacturer and importer MDRs with 7-digit sequence numbers | MDRs with a 7-digit sequence number in F2 Importer Report Number or G8 Manufacturer Report Number will be accepted by eMDR. This update will expand the total number of MDRs that the highest volume submitters can submit within a single year. Note that the sequence number length will remain limited to 5 digits in eSubmitter. |
December 1, 2023: Test deployment to eMDR. January 2024: Production deployment to eMDR. |
| International Medical Device Regulators Forum (IMDRF) 2023 maintenance updates | The Adverse Event codes accepted in sections F10 and H6 of the Form 3500A will be updated to harmonize with maintenance updates from IMDRF. To see a summary of the changes and download the new hierarchy files, go to Coding Resources. |
December 1, 2023: Test deployment to eMDR. January 2024: eSubmitter users can begin using this field. AS2 users to implement this field by June 1, 2024. |
Historical Changes to eMDR
| Change | Comments | Schedule |
|---|---|---|
| 2022 eMDR Enhancements | 2022 Enhancements include:
|
|
| IMDRF 2021 maintenance updates | The Adverse Event codes accepted in sections F10 and H6 of the 3500A form were updated to harmonize with maintenance updates from IMDRF. To see a summary of the changes and download the new hierarchy files, go to Coding Resources. Industry with system-to-system, or AS2, accounts with the FDA Electronic Submissions Gateway (ESG), should update their systems as soon as possible to match. | Test deployment to eMDR on February 21, 2021. Production deployment to eMDR and eSubmitter on March 5, 2021. |
| Exemption Number field added 2020 |
A new element indicating the Exemption Number associated with the MDR (if any) was added to eMDR and eSubmitter, so submitters need not report this information in Section H10 (Additional Manufacturer Narrative) with precise text formatting. Submitters should cease reporting exemption numbers in H10, and instead use this new Exemption Number field. | Test deployment to eMDR on August 14, 2020. Production deployment to eMDR and eSubmitter on September 7, 2020. |
| Overview of updates to the FDA Form 3500A with expiration date 2021-Nov-30 2020 |
The eMDR system was updated to include fields from the newest version of the FDA Form 3500A. The additions included new options in A3 Patient Gender, new fields for C6 Generic and Biosimilar, a new field for D8 Device Serviced By a Third Party, new options for E3 Reporter Occupation, a new field for G4 PreANDA, a new field for G5 Combination Product, new fields in H1 for Summary Report, for example, Voluntary Malfunction Summary Reports (VMSR) and Number of Events (see NOE update below), and new fields for H6 Health Effect Impact Code and Medical Device Component Code (see International Medical Device Regulators Forum (IMDRF) Annex E, F, G codes updates below). AS2 submitters should refer to the eMDR Implementation Package for a complete list of changes. |
Test deployment to eMDR on August 14, 2020. Production deployment to eMDR and eSubmitter on September 7, 2020. |
| IMDRF Annex E, F, G code updates 2020 |
The Adverse Event codes accepted in F10 and H6 were updated to complete harmonization with the IMDRF Adverse Event Reporting Terminologies. This update added new code sets for Annexes E (Patient Problem Code, now called Health Effect Clinical Code), F (Health Effect Impact Code), and G (Medical Device Component Code), as well as maintenance updates (including new codes) for the Medical Device Problem Code set (Annex A). A new field for component codes was added to the FDA Form 3500A with expiration date 2021-Nov-30 and they will no longer be accepted in other code fields. All FDA code sets were renamed to their IMDRF names, and IMDRF codes are now accepted by eMDR in addition to the corresponding FDA and National Cancer Institute Thesaurus (NCIt) codes. For more information on the new and retired codes, please view the hierarchy and disposition files posted at MDR Adverse Event Codes. eMDR began rejecting MDRs containing Patient Problem codes and Device Component codes retired during this update on March 5, 2021. | Test deployment to eMDR on August 14, 2020. Production deployment to eMDR and eSubmitter on September 7, 2020. |
| Summary Report and NOE fields added 2020 |
As part of the update to the FDA Form 3500A with expiration date 2021-Nov-30, new elements for Summary Report and NOE (Number of Events) for use in summary MDR reporting were added to H1, so that submitters will not need to report this information in B5 (Event Narrative) with precise text formatting. These elements should be used for all summary MDR reporting, for example, VMSR. Submitters should cease reporting NOE elements in B5. | Test deployment to eMDR on August 14, 2020. Production deployment to eMDR and eSubmitter on September 7, 2020. |
| Country code formats clarification 2020 |
The eMDR implementation package was updated to clarify the formatting of country codes in the address fields. Two-letter codes are interpreted as FIPS 10-4 and three-letter codes are interpreted as GENC. AS2 submitters should not send ISO 3166-1 two-letter and three-letter country codes to eMDR. Refer to the eMDR Implementation Package for a complete list of accepted country codes. | Effective May 28, 2020. |
| Supplement Numbering Requirements Enforcement 2018 |
The eMDR system was updated to enforce requirements related to supplement report numbering. In the past, supplements that were sent with incorrect follow-up numbers (for example, a supplement #2 for a report without supplement #1) would be accepted and placed into "supplement hold" while the eMDR system waited for the missing supplement(s) to arrive. Now, a supplement with an incorrect follow-up number will be rejected, and Ack3 will contain a message explaining which follow-up numbers are missing for the report in question. For more information on the new Ack3 error messages, please view the sample acknowledgement files in the eMDR Implementation Package. | Production deployment to eMDR on December 27, 2018. |
| FDA Adverse Event codes update 2018 |
The list of the FDA's Adverse Event codes accepted in F10 and H6 was updated to harmonize with the IMDRF Adverse Event Reporting Terminologies. This update affected the Device Problem Codes and Manufacturer Evaluation Codes, which correspond to IMDRF Annexes A through D. Future updates will harmonize all remaining FDA adverse event codes with IMDRF as more annexes are published. IMDRF codes are not accepted by eMDR, but the new hierarchies posted on FDA.gov include a one-to-one mapping of IMDRF codes to the FDA's codes. AS2 submitters who use the FDA's codes retired during this update will have their report rejected by eMDR. For more information on the new and retired codes, please view the hierarchy and disposition files posted at MDR Adverse Event Codes. | Test deployment to eMDR on March 6, 2018. Production deployment to eMDR and eSubmitter on July 5, 2018. |
| Environment and Submission Type elements added to Ack3 2017 |
A new element indicating the submission environment (production or test) was added to both the HTML and XML Ack3. This element allows submitters to detect when they have accidentally submitted to the wrong environment. Also, a new element indicating the CDRH submission type (FDA Form 3500A for eMDR) was added to both versions of Ack3. | Test deployment to eMDR on April 7, 2017. Production deployment to eMDR on October 2, 2017. |
| HL7 ICSR R2 XML format update 2017 |
The eMDR system was updated to accept HL7 ICSR R2 format XML, and eSubmitter was updated to generate R2 XML for all submissions. Although the R2 schema allows for multiple devices and multiple patients in a single report, eMDR will continue to accept only one device and one patient per report. AS2 submitters can indicate whether their XML is in R1 or R2 format using a new schema element (submissions without this element will continue to be processed as R1). After a one-year grace period, eMDR ceased accepting R1 format submissions on July 5, 2018. | Production deployment to eMDR and eSubmitter on June 29, 2017. |
| Combination product fields added 2017 |
The new eMDR ICSR R2 XML includes elements from sections C and G of the FDA Form 3500A that contain drug information. This allows submitters to include information of up to 20 drugs within a device-led combination product adverse event report in eMDR. | Production deployment to eMDR and eSubmitter on June 29, 2017. |
| FDA Form 3500A version 9/30/2018 updates 2017 |
The eMDR system was updated to include fields from the newest version of the FDA Form 3500A. The major addition was section A5 (Ethnicity/Race). This field is not mandatory for eMDR submissions, but the FDA requested that AS2 submitters add this field to their systems by July 5, 2018. | Production deployment to eMDR and eSubmitter on June 29, 2017. |
| D4 UDI guidance update 2017 |
Submitters were previously instructed to enter the full human-readable UDI in the D4 UDI field. This guidance has been updated to request that manufacturers include only the DI portion of the UDI in this field. User Facility reporters that are not aware of the suspect medical device's DI should continue to enter the full human-readable UDI printed on the device. | Effective June 1, 2017. |
| Mandatory B5 and H1 2017 |
Manufacturer initial reports must include a value for B5 and H1. Reports that contain only whitespace for B5 will be rejected. Reports that do not indicate Death, Serious Injury, or Malfunction in H1 will be rejected. | Production deployment to eMDR and eSubmitter on February 2, 2017. |